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Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients

Primary Purpose

Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Standard follow-up
Telemonitoring
Sponsored by
Sociedad Española de Neumología y Cirugía Torácica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Apnea Syndrome focused on measuring CPAP compliance, Telemonitoring, Standard management, Cost effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and Women over 18 years old
  • Diagnosed as OSA and requiring CPAP treatment
  • Written informed consent form signed.

Exclusion Criteria:

  • Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders)
  • Severe heart failure
  • Severe chronic pathology associated
  • Psychiatric disorder
  • Periodic leg movements
  • Pregnancy
  • Other dyssomnias or parasomnias
  • Patients already treated with CPAP

Sites / Locations

  • Hospital Arnau de Vilanova-Santa María

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard follow up-Sleep Unit

Telemonitoring

Arm Description

Patients diagnosed as OSA, treated with CPAP and followed up in sleep unit

Patients diagnosed as OSA and treated with CPAP in sleep unit, followed up by telemonitoring system

Outcomes

Primary Outcome Measures

CPAP adherence at 3 months
Number of hours of use per day of CPAP according to the internal clock of the CPAP device

Secondary Outcome Measures

Patients' satisfaction at 3 months
Patients will be asked to grade their satisfaction with the follow up care provided by telemonitoring /sleep unit using a questionnaire and a visual analogue scale.
Cost effectiveness at 3 months
Costs in each group (CPAP carrying charge, number of visits and calls, number of hospital admissions) will be compared.
Change from baseline in quality of life at 3 months
EuroQOL health questionnaire and visual analogue scale will be used.
Fast detection of the non-adherent patient with telemonitoring
We assume that telemonitoring could quickly detect non- adherent patients.
Change in blood pressure at 3 months
Change in body mass index at 3 months
Abandons at 3 months
Number of patients lost at follow up at 3 months of CPAP therapy.
Adverse events at 3 months
Change from baseline in snoring at 3 months
Patients will be asked about the persistence of snoring
Change from baseline in witnessed apneas at 3 months
Patients will be asked about the persistence of witnessed apneas
Change from baseline in nocturia at 3 months
Patients will be asked about the presence of nocturia.
Change from baseline in daytime sleepiness at 3 months
Epworth sleepiness scale will be used.
Changes in nocturnal gasping at 3 months
Patients will be asked about the persistence of nocturnal gasping
Changes in sleep fragmentation at 3 months
Patients will be asked about the persistence of sleep fragmentation/maintenance insomnia
Presence of symptoms of restlees leg syndrome at 3 months
Patients will be asked about the presence of symptoms of restless leg syndrome

Full Information

First Posted
July 30, 2015
Last Updated
April 14, 2016
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Collaborators
ResMed, Asociacio Lleidatana de Respiratori
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1. Study Identification

Unique Protocol Identification Number
NCT02517346
Brief Title
Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients
Official Title
Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Collaborators
ResMed, Asociacio Lleidatana de Respiratori

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).
Detailed Description
Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension , cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The application of a continuous positive airways pressure (CPAP) represents the first line therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness and oxygen saturation , reduces cardiovascular risk, ameliorates neurobehavioral performance, improves quality of life and reduces road accidents. Despite its demonstrated efficacy, CPAP effectiveness is significantly limited by poor adherence. A closer follow up could improve CPAP adherence but it would take up more work and additional costs for sleep units. So on that account, the investigators propose a study to demonstrate that automatic home treatment monitoring of patients with OSA is a cost-effectiveness alternative approach to patient's management. Moreover, the investigators believe that telemonitoring could improve CPAP compliance and patient's satisfaction and reduce follow-up costs. Methods: Prospective and randomized study during three months. Patients diagnosed as OSA in St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment, will be randomized into two groups differing in CPAP compliance monitoring and management . Group 1 Standard care Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Patients will follow the standard treatment management. All patients will be visited at 1 month at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine. Information will be downloaded from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual respiratory events…). Group 2 Telemonitoring Patients will be fitted with a mask and given a CPAP. Each CPAP device will be provided with a modem sending daily compliance information (CPAP adherence, CPAP pressure, mask leak, and residual respiratory events) to a web database. Patients of both 2 groups will be finally visited at 3 months at sleep unit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome
Keywords
CPAP compliance, Telemonitoring, Standard management, Cost effectiveness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard follow up-Sleep Unit
Arm Type
Active Comparator
Arm Description
Patients diagnosed as OSA, treated with CPAP and followed up in sleep unit
Arm Title
Telemonitoring
Arm Type
Experimental
Arm Description
Patients diagnosed as OSA and treated with CPAP in sleep unit, followed up by telemonitoring system
Intervention Type
Other
Intervention Name(s)
Standard follow-up
Intervention Description
Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
Intervention Type
Other
Intervention Name(s)
Telemonitoring
Intervention Description
Follow up by telemonitoring system during 3 months
Primary Outcome Measure Information:
Title
CPAP adherence at 3 months
Description
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patients' satisfaction at 3 months
Description
Patients will be asked to grade their satisfaction with the follow up care provided by telemonitoring /sleep unit using a questionnaire and a visual analogue scale.
Time Frame
3 months
Title
Cost effectiveness at 3 months
Description
Costs in each group (CPAP carrying charge, number of visits and calls, number of hospital admissions) will be compared.
Time Frame
3 months
Title
Change from baseline in quality of life at 3 months
Description
EuroQOL health questionnaire and visual analogue scale will be used.
Time Frame
3 months
Title
Fast detection of the non-adherent patient with telemonitoring
Description
We assume that telemonitoring could quickly detect non- adherent patients.
Time Frame
3 months
Title
Change in blood pressure at 3 months
Time Frame
3 months
Title
Change in body mass index at 3 months
Time Frame
3 months
Title
Abandons at 3 months
Description
Number of patients lost at follow up at 3 months of CPAP therapy.
Time Frame
3 months
Title
Adverse events at 3 months
Time Frame
3 months
Title
Change from baseline in snoring at 3 months
Description
Patients will be asked about the persistence of snoring
Time Frame
3 months
Title
Change from baseline in witnessed apneas at 3 months
Description
Patients will be asked about the persistence of witnessed apneas
Time Frame
3 months
Title
Change from baseline in nocturia at 3 months
Description
Patients will be asked about the presence of nocturia.
Time Frame
3 months
Title
Change from baseline in daytime sleepiness at 3 months
Description
Epworth sleepiness scale will be used.
Time Frame
3 months
Title
Changes in nocturnal gasping at 3 months
Description
Patients will be asked about the persistence of nocturnal gasping
Time Frame
3 months
Title
Changes in sleep fragmentation at 3 months
Description
Patients will be asked about the persistence of sleep fragmentation/maintenance insomnia
Time Frame
3 months
Title
Presence of symptoms of restlees leg syndrome at 3 months
Description
Patients will be asked about the presence of symptoms of restless leg syndrome
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and Women over 18 years old Diagnosed as OSA and requiring CPAP treatment Written informed consent form signed. Exclusion Criteria: Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders) Severe heart failure Severe chronic pathology associated Psychiatric disorder Periodic leg movements Pregnancy Other dyssomnias or parasomnias Patients already treated with CPAP
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferran Barbe, MD
Organizational Affiliation
Hospital Arnau de Vilanova. IRB Lleida. CIBERes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Arnau de Vilanova-Santa María
City
Lleida
ZIP/Postal Code
25198
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28179438
Citation
Turino C, de Batlle J, Woehrle H, Mayoral A, Castro-Grattoni AL, Gomez S, Dalmases M, Sanchez-de-la-Torre M, Barbe F. Management of continuous positive airway pressure treatment compliance using telemonitoring in obstructive sleep apnoea. Eur Respir J. 2017 Feb 8;49(2):1601128. doi: 10.1183/13993003.01128-2016. Print 2017 Feb.
Results Reference
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Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients

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